Background/Objective: In recent years, treatment of heart failure patients has proved to benefit from implantation of pressure sensors in the pulmonary artery (PA). While longitudinal measurement of PA pressure profoundly improves a clinician’s ability to manage HF, the full potential of central venous pressure as a clinical tool has yet to be unlocked. Central venous pressure serves as a surrogate for the right atrial pressure, and thus could potentially predict a wider range of heart failure conditions. However, it is unclear if current sensor anchoring methods, designed for the PA, are suitable to hold pressure sensors safely in the inferior vena cava. The purpose of this study was to design an anchoring system for accurate apposition in inferior vena cava and evaluate whether it is a potential site for central venous pressure measurement. Materials and Methods: A location inferior to the renal veins was selected as an optimal site based on a CT scan analysis. Three anchor designs, a 10-strut anchor, and 5-struts with and without loops, were tested on a custom-made silicone bench model of Vena Cava targeting the infra-renal vena cava. The model was connected to a pulsatile pump system and a heated water bath that constituted an in-vitro simulation unit. Delivery of the inferior vena cava implant was accomplished using a preloaded introducer and a dilator as a push rod to deploy the device at the target area. The anchors were subjected to manual compression tests to evaluate their stability against dislodgement. Computational Fluid Dynamics (CFD) analysis was completed to characterize blood flow in the anchor’s environment using pressure-based transient solver. Any potential recirculation zones or disturbances in the blood flow caused by the struts were identified. Results: We demonstrated successful anchorage and deployment of the 10-strut anchor in the Vena Cava bench model. The 10-strut anchor remained stable during several compression attempts as compared with the other two 5-strut anchor designs. The 10-strut design provided the maximum number of contact points with the vessel in a circular layout and was less susceptible to movement or dislodgement during compression tests. Furthermore, the CFD simulation provided haemodynamic analysis of the optimum 10-strut anchor design. Conclusions: This study successfully demonstrated the design and deployment of an inferior vena cava anchoring system in a bench test model. The 10-strut anchor is an optimal design as compared with the two other 5-strut designs; however, substantial in-vivo experiments are required to validate the safety and accuracy of such implants. The CFD simulation enabled better understanding of the haemodynamic parameters and any disturbances in the blood flow due to the presence of the anchor. The ability to place a sensor technology in the vena cava could provide a simple and minimally invasive approach for heart failure patients.

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Background/Objective: Optimization of needle characteristics for trans-septal puncture is of paramount importance to reduce the extent of tissue deformation. This was achieved by studying the mechanical behavior of fossa ovalis (FO) in lamb hearts. The fossa ovalis tissue samples obtained after dissection were subjected to experimental indentation and tensile tests to determine tissue deformation. Methods: Lamb hearts (n = 20) were dissected to obtain fossa ovalis tissue samples. These were subjected to indentation and tensile tests to determine the puncture and rupture forces respectively. Indentation tests were performed using two different indenters: A steel indenter with a hemispherical tip and a Brockenbrough (BRK) needle (bevel tip). Tensile tests were formed using Zwick Roell (Z005) tensile machine at 100 N load cell. ImageJ analysis was also performed to determine the diameter and shape of FO. Results: Indentation results demonstrated that the hemispherical indenter requires a greater punch force compared to the puncture force with the BRK needle. The mean punch force of the hemispherical indenter (15.57 N) was nearly 3 times greater than the puncture force of the BRK needle (5.47 N). Variations between the two indenters provide an insight into the importance of device geometry on trans-septal procedures. The tensile test results illustrated a typical failure pattern with a toe region, linear region, and failure region. The mean rupture force determined was 10.51 N. ImageJ analysis confirmed an oval shape of FO and the diameters measured were in the range 9.0–15.3 mm. Conclusions: The mechanical aspects of fossa ovalis in lamb hearts were successfully studied through a series of experimental indentation and tensile tests. This study serves as a guide to dissecting the challenging FO sample. The procedures for indentation and tensile tests are detailed with common experimental challenges encountered addressed. The correlation of the parameters involved in these experimental tests to the collagen fiber orientation in tissues is also discussed, providing an insight into the deformation of tissues and variations in fiber orientation before and after trans-septal procedures.